A Pilot Feasibility Trial of an Upper Extremity Assistive System.

Only five participants were analyzed, and the paper says this sample is too small for meaningful statistical tests. There was no control group, so improvement cannot be compared with usual therapy or no therapy. Participants received the NuroSleeve, occupational therapy, and home practice together, so the contribution of any one part cannot be separated. Two enrolled participants did not complete therapy because elbow and shoulder limitations required new device components. Some outcome measures were not collected because of fatigue or coordinator error. Several COPM tasks relied on elbow, shoulder, or the other hand, so they could not show whether the sleeve itself caused change. PROMIS scores do not show which hand was used, so they cannot separate affected-limb improvement from other-hand compensation. Participants and therapists knew they were using the device, and the assessor was not described as blinded.

Do not read the improvements as proof the NuroSleeve works. This was a single-arm pilot with no control group, and participants received the device, occupational therapy, and home practice together, so their separate effects cannot be separated.